510(k) K251128

Extremity Medical External Fixation System by Extremity Medical, LLC — Product Code KTT

K251128 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "Extremity Medical External Fixation System". The FDA issued a decision of Substantially Equivalent on May 7, 2025. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.